Biomarker Cost-Benefit Analysis of EFNEP

A Cost-Benefit Analysis of EFNEP Utilizing Biomarkers of Chronic Disease Risk

The goal of this integrated project is to assess whether EFNEP is a cost-effective nutrition education intervention that generates sustained improvement in chronic disease biomarkers. This project will be unique in its use of objective biomarkers, instead of self-reported behaviors, to quantify the economic benefits generated by EFNEP through chronic disease prevention. A paired location untreated control group quasi-experimental design will be employed, with biomarkers (BMI, blood pressure, HbA1c) measured for 500 adults across four representative state EFNEP programs (CO, FL, MD, WA). Biomarkers will be measured pre-EFNEP, 6-months-post-EFNEP and 1-year-post-EFNEP. Analytical techniques will include cost-benefit, bivariate, and multivariate analyses.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Expanded Food and Nutrition Education Program (EFNEP)

Detailed Description

According to the CDC, 60% of US adults have a diagnosed chronic disease. This indicates the need for focused efforts to change modifiable risk factors including diet and exercise. The Expanded Food and Nutrition Education Program (EFNEP) aims to prevent chronic diseases by educating and encouraging vulnerable populations to adopt a healthy diet and physical activity. Addressing the program priority area Diet, Nutrition and the Prevention of Chronic Diseases, the long-term goal of this integrated project is to assess whether EFNEP is a cost-effective nutrition education intervention that generates sustained improvement in chronic disease biomarkers. This project will be unique in its use of objective biomarkers, instead of self-reported behaviors, to quantify the economic benefits generated by EFNEP through chronic disease prevention.

Project research objectives include analyzing EFNEP's sustained impact on chronic disease biomarkers and developing and applying a biomarker-based cost-benefit analysis methodology. Extension objectives are to develop an online cost-benefit analysis tool and webinar for nutrition education program evaluation. Education objectives are to provide graduate students with experiential learning opportunities in data collection and analysis.

A paired location untreated control group quasi-experimental design will be employed, with biomarkers (BMI, blood pressure, HbA1c) measured for 500 adults across four representative state EFNEP programs (CO, FL, MD, WA). Biomarkers will be measured pre-EFNEP, 6-months-post-EFNEP and 1-year-post-EFNEP. Analytical techniques will include cost-benefit, bivariate, and multivariate analyses. Project results will expand the EFNEP knowledge-base, allowing for program content and delivery modifications that maximize the impact of taxpayer dollars allocated to chronic disease prevention.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Not yet recruiting
      • Colorado State University
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida
  • Maryland
    • College Park, Maryland, United States, 20742
      • Recruiting
      • University of Maryland
  • Washington
    • Pullman, Washington, United States, 99164
      • Recruiting
      • Washington State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Free-Living
• Speaks and understands English and/or Spanish
• Income at or below 185% of the Federal Poverty Line

Exclusion Criteria:

• Being pregnant, nursing, and/or less than 9-months postpartum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EFNEP Group; Subjects will receive the EFNEP Eat Smart Being Active class series.	Behavioral: Expanded Food and Nutrition Education Program (EFNEP); Subjects will participate in nine hands-on EFNEP lessons to teach nutrition, healthy lifestyle choices, physical activity, food preparation, food safety, and food resource management.
No Intervention: Control Group; Subjects will receive no EFNEP intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Height from Baseline to 6 Months Post Intervention	Height (m) is measured using a portable stadiometer.	Change in height measurement from baseline to 6 months post intervention
Change in Height from Baseline to 12 Months Post Intervention	Height (m) is measured using a portable stadiometer.	Change in height measurement from baseline to 12 months post intervention
Change in Weight from Baseline to 6 Months Post Intervention	Weight (kg) is measured using a portable scale.	Change in weight measurement from baseline to 6 months post intervention
Change in Weight from Baseline to 12 Months Post Intervention	Weight (kg) is measured using a portable scale.	Change in weight measurement from baseline to 12 months post intervention
Change in Systolic and Diastolic Blood Pressure from Baseline to 6 Months Post Intervention	Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor	Change in Systolic and Diastolic blood pressure measurements from baseline to 6 months post intervention
Change in Systolic and Diastolic Blood Pressure from Baseline to 12 Months Post Intervention	Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor	Change in Systolic and Diastolic blood pressure measurements from baseline to 12 months post intervention
Change in HbA1c from Baseline to 6 Months Post Intervention	HbA1c is measured using A1CNow monitor.	Change in HbA1c measurement from baseline to 6 months post intervention
Change in HbA1c from Baseline to 12 Months Post Intervention	HbA1c is measured using A1CNow monitor.	Change in HbA1c measurement from baseline to 12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention	The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.	Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention	The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.	Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention	24-hour dietary recalls will be administered to capture change in food and beverage intake.	Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention	24-hour dietary recalls will be administered to capture change in food and beverage intake.	Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
Participant Demographics Baseline	A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status.	Baseline.
Participant Demographics Post Intervention	A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.	Immediately Post Intervention.
Participant Demographics 6 Months Post Intervention	A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.	6 Months Post Intervention
Participant Demographics 12 Months Post Intervention	A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.	12 Months Post Intervention
Participant Health Status Baseline	A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.	Baseline
Participant Health Status 6 Months Post Intervention	A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.	6 Months Post Intervention
Participant Health Status 12 Months Post Intervention	A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.	12 Months Post Intervention

Collaborators and Investigators

• Sponsor: South Dakota State University
• Collaborators: University of Florida; Washington State University; Michigan State University; Colorado State University; University of Idaho; University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Diet; Nutrition Education; Cost-benefit analysis; EFNEP
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 1843412-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data will be made available on South Dakota State University's Open Access Institutional Repository, Open PRAIRIE.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No